After undergoing a series of treatments for cancer, Scott Goedeke was faced with the reality that the cancer had spread from the roof of his mouth to a lymph node in his neck. The 58-year-old health-care consultant agreed to an experimental treatment that would use his own cells to destroy the cancer. His medical team extracted a tumor, identified the cells that could attack the disease, and multiplied them in a lab. After infusing billions of cells back into his body, the tumor had shrunk significantly after six weeks.
The experimental therapy that Goedeke underwent has now been approved by the U.S. Food and Drug Administration. This therapy is now approved for the treatment of adults with a skin cancer like Goedeke’s — melanoma that has spread or can’t be removed with surgery, after other approaches have failed. Cancer experts say that this approval could mark the beginning of a potent new weapon against far more common tumors.
Shares of the company that makes the therapy surged more than 30 percent on the first full day of trading following the FDA’s approval. The therapy, called tumor-infiltrating lymphocytes, enlists the relatively small number of the body’s T cells that see a tumor as a threat and produces a lab-grown army of them. Of the 73 patients treated in a clinical trial, 31.5 percent of them had their tumors decrease in size or disappear after the cell treatment, the FDA said.
The FDA approval is “the first step in realizing the company’s ambition to usher in the next generation of cell therapy by bringing this breakthrough to patients with advanced solid tumors,” the company’s interim chief executive said in a statement.
After undergoing chemotherapy to prepare his body for the cell therapy, Goedeke was relieved to find out that he was a “responder” to the experimental therapy. He expressed his happiness that other patients will be able to access this therapy after the FDA’s approval.
